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Eliquis (Apixaban) - Summary

 
 



WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS

(B) SPINAL/EPIDURAL HEMATOMA

(A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS

Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration, Warnings and Precautions, and Clinical Studies].

(B) SPINAL/EPIDURAL HEMATOMA

Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

  • use of indwelling epidural catheters
  • concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
  • a history of traumatic or repeated epidural or spinal punctures
  • a history of spinal deformity or spinal surgery
  • optimal timing between the administration of ELIQUIS and neuraxial procedures is not known

[see Warnings and Precautions ]

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions].

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions].

 

ELIQUIS SUMMARY

ELIQUIS (apixaban) is a factor Xa (FXa) inhibitor.

Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation

ELIQUIS® (apixaban) is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

Treatment of Deep Vein Thrombosis

ELIQUIS is indicated for the treatment of DVT.

Treatment of Pulmonary Embolism

ELIQUIS is indicated for the treatment of PE.

Reduction in the Risk of Recurrence of DVT and PE

ELIQUIS is indicated to reduce the risk of recurrent DVT and PE following initial therapy.


See all Eliquis indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Eliquis (Apixaban)

Initial 3-Weeks' Apixaban Versus Dual-Antiplatelet Therapy (Clopidogrel and Aspirin) Followed by Clopidogrel Alone in High-Risk Patients with Acute Non-Disabling Cerebrovascular Events (ADANCE): Study Protocol for a Randomized Controlled Trial. [2014]
BACKGROUND: Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial demonstrated that dual-antiplatelet therapy (clopidogrel and aspirin), compared with aspirin monotherapy, reduced the risk of recurrent stroke and was not associated with increased risk of hemorrhagic events...

Apixaban vs. warfarin with concomitant aspirin in patients with atrial fibrillation: insights from the ARISTOTLE trial. [2014]
CONCLUSION: Apixaban had similar beneficial effects on stroke or systemic

High-sensitivity troponin T and risk stratification in patients with atrial fibrillation during treatment with apixaban or warfarin. [2014]
events and mortality... CONCLUSIONS: Levels of hs-TnT are often elevated in patients with AF. The hs-TnT

The effects of apixaban on hospitalizations in patients with different types of atrial fibrillation: insights from the AVERROES trial. [2013]
CONCLUSION: In AVERROES, patients on apixaban therapy were less likely to be

Randomized, double-blind trial to evaluate the safety of apixaban with antiplatelet therapy after acute coronary syndrome in Japanese patients (APPRAISE-J). [2013]
CONCLUSIONS: The bleeding profile of apixaban in Japanese patients with ACS was

more studies >>

Clinical Trials Related to Eliquis (Apixaban)

Bioavailability of Apixaban Crushed Tablet [Completed]
The purpose of this study is to determine whether the bioavailability of apixaban crushed tablets suspended in water or mixed with applesauce is similar to the bioavailability of apixaban whole tablets administered orally.

Apixaban Versus Dual-antiplatelet Therapy (Clopidogrel and Aspirin) in Acute Non-disabling Cerebrovascular Events [Not yet recruiting]
Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke. A recent trial indicated that clopidogrel and aspirin treatment reduced the risk of recurrent stroke and was not associated with increased hemorrhage events, compared with aspirin monotherapy. Apixaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants with less risk of bleeding events. To estimate whether apixaban is beneficial for acute TIA or minor stroke, a randomized, double-blind, multicenter, controlled clinical trial has been designed. The investigators will assess the hypothesis that a 21-days apixaban regimen is superior to clopidogrel and aspirin dual-therapy for the treatment of high-risk patients with acute nondisabling cerebrovascular event.

A Study to Assess the Effects of 2 Prothrombin Complex Concentrates on the Pharmacodynamics of Apixaban in Healthy Adult Subjects [Completed]
The purpose of this study is to assess the effect of two 4-Factor PCC formulations on Apixaban pharmacodynamics in healthy adult subjects.

Early Post-marketing Study of Eliquis (Apixaban) [Active, not recruiting]
The primary objective of the study is to identify and describe any suspected (AEs) in all patients with NVAF treated with Apixaban, as a request of the National Center of Pharmacovigilance (CNFV) in Mexico.

Phase 1 Oral Solution Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects [Completed]
The purpose of this study is to assess the bioavailability of Apixaban solution administered through NGT and washed with Dextrose 5% in water (D5W) or infant formula relative to Apixaban solution administered orally in healthy subjects

more trials >>


Page last updated: 2015-08-10

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